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Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity (INTREPiD)
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.
Details
| Lead sponsor | Duke University |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 2174 |
| Start date | 2023-11-06 |
| Completion | 2026-12 |
Conditions
- Malaria,Falciparum
- Malaria in Pregnancy
- Malaria in Childbirth
- Pregnancy
- Neonatal Health
- Low Birthweight
- Stillbirth
- Gestational Age and Weight Conditions
- Preterm Birth
Interventions
- Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)
- Artemether-lumefantrine (AL)
Primary outcomes
- Composite number of adverse pregnancy outcomes — Enrollment to 28 days Post-delivery (including each antenatal care visit)
Adverse pregnancy outcomes defined as low birth weight (\<2500 grams) OR preterm (\< 37 0/7 weeks) OR small for gestational age (GA) (\< 10th percentile weight for GA) OR pregnancy loss, defined as a. spontaneous abortion ( loss \< 22 0/7 weeks gestation) OR b. stillbirth (loss ≥ 22 0/7 weeks gestation) OR neonatal death (livebirth with death prior to the 28th day of life).
Countries
Democratic Republic of the Congo, Kenya